A national cross-sectional survey of constipation in patients attending cancer centres in Ireland

Karen Ryan; Bridget M. Johnston; Clare McAleer; Laserina O'Connor; Philip Larkin

doi:10.12688/hrbopenres.13315.1

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Research Article

A national cross-sectional survey of constipation in patients attending cancer centres in Ireland

[version 1; peer review: 2 approved with reservations]

Karen Ryan ^1-3, Bridget M. Johnston⁴, Clare McAleer², Laserina O'Connor⁵, Philip Larkin⁶

Karen Ryan ^1-3, Bridget M. Johnston⁴, [...] Clare McAleer², Laserina O'Connor⁵, Philip Larkin⁶

PUBLISHED 15 Oct 2021

Author details Author details

¹ University College Dublin, Dublin, D04 V1W8, Ireland
² St Francis Hospice Dublin, Dublin, D15 DE98, Ireland
³ Department of Palliative Medicine, Mater Misericordiae University Hospital, Dublin, D07 AX57, Ireland
⁴ Centre for Health Policy and Management, Trinity College Dublin, Dublin, D02 PN40, Ireland
⁵ School of Nursing, Midwifery and Health Systems, University College Dublin, Dublin, D04 V1W8, Ireland
⁶ Palliative and Supportive Care Service, Chair of Palliative Nursing, Lausanne University Hospital, Lausanne, CH-1011, Switzerland

Karen Ryan
Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Bridget M. Johnston
Roles: Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Clare McAleer
Roles: Formal Analysis, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Laserina O'Connor
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

Philip Larkin
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Supervision, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

Abstract

Background: The prevalence of constipation in patients with cancer is estimated at 50-90%. It is often associated with pain, anorexia, nausea and vomiting and impacts negatively on quality of life.
Despite its common occurrence, it is often poorly recognised and treated by healthcare professionals.
Methods: A national cross-sectional survey was conducted in Ireland to describe constipation prevalence and severity in patients attending cancer centres and to evaluate management efficacy. In-patients or patients attending day oncology wards in any of the country’s eight designated cancer centres were eligible to participate. Participants were shown the Bristol Stool Chart and answered questions regarding stool appearance and sensation of incomplete defecation; they completed the Constipation Assessment Scale. Data on pain character and intensity, opioid use, and prescribed and over-the-counter laxative use were collected. Data were summarised using descriptive statistics. Significance of variations for continuous data were determined using t-tests. Conditional ordered logistic regression was undertaken to determine factors associated with constipation.
Results: The dataset comprised 491 patients. 24.8% had been reviewed by specialist palliative care; 14.5% by the anaesthetic pain team. In total, 42.2% of respondents were taking step 2 or step 3 opioids. Constipation prevalence was 67.6%; 19.4% of patients had Constipation Assessment Scale scores indicating severe constipation. A total of 46% of the respondents were not taking any laxatives. Of those who were taking laxatives, 54.8% reported constipation symptoms. While opioid use was strongly associated with participants reporting higher scores, this association was not seen in those patients receiving specialist palliative care.
Conclusions: Constipation remains a clinical problem in Irish cancer centres. Despite increased opioid use, patients receiving specialist palliative care were more likely to take laxatives and reported less constipation. Specialist palliative care practice should be studied in order to identify what are the transferable ‘ingredients’ of effective constipation management.

Keywords

Constipation, neoplasms, guideline, palliative care, prevalence, cross-sectional studies

Corresponding author: Karen Ryan

Competing interests: No competing interests were disclosed.

Grant information: This project was funded by a grant awarded to Prof. Laserina O’Connor and Prof. Philip Larkin from the Department of Health, Health Service Executive and Irish Cancer Society (01092016PCPPS).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2021 Ryan K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Ryan K, Johnston BM, McAleer C et al. A national cross-sectional survey of constipation in patients attending cancer centres in Ireland [version 1; peer review: 2 approved with reservations]. HRB Open Res 2021, 4:113 (https://doi.org/10.12688/hrbopenres.13315.1) First published: 15 Oct 2021, 4:113 (https://doi.org/10.12688/hrbopenres.13315.1) Latest published: 14 Jun 2022, 4:113 (https://doi.org/10.12688/hrbopenres.13315.2)

Introduction

Ireland has well-developed cancer and palliative care services and there is a growing focus on evidence-based practice and the development of learning healthcare systems¹. The management of cancer-related constipation has emerged as an area for improvement because it is a common condition that impacts negatively on quality of life, yet remains poorly recognised and treated^2–4. Accordingly, a national clinical guideline focused on constipation management for patients receiving palliative care was published in 2015⁵.

This study was carried out to establish the prevalence of constipation in patients attending cancer centres and to assess the efficacy of treatment. Little is known of the extent of constipation burden experienced by patients with cancer in Ireland. Reliable information on management efficacy is lacking. The data will be of value as a source of comparative data given relative paucity of recent prevalence studies in cancer populations^6–8. We hope to stimulate consideration of the factors associated with improved outcomes and re-double efforts to reduce constipation burden.

Methods

Ethics statement

Ethical approval was obtained in each cancer centre (Beaumont Hospital Research Ethics Committee – Ref: 17/48; Galway University Hospitals: C.A. 1739; HSE South-Eastern Area Research Ethics Committee - approval date: 24.05.17; Mater Misericordiae University Hospital Research Ethics Committee Ref: 1/378/1913; St James’s Hospital /AMNCH Research Ethics Committee Ref: 2017-05 Chairman’s Action (10); St Vincent’s Ethics and Medical Research Committee - approval date 19.04.17; University College Cork Clinical Research Ethics Committee – Ref: ECM 4 (m) 09/05/17; University Hospital Limerick, Research Ethics Committee Ref: 062/17) and the lead University (University College Dublin Research Ethics Committee LS-E-17-105-O’Connor; 16.6.17). Written, signed informed consent was obtained via signature from each participant for data collection (survey and chart review) and publication of results.

Study design and subjects

A cross-sectional point prevalence study was carried out in the eight designated cancer centres in Ireland in 2017 (Beaumont Hospital, Galway University Hospital, University Hospital Waterford, Mater Misericordiae University Hospital, St James’s Hospital, St Vincent’s University Hospital, Cork University Hospital, University Hospital Limerick).

Pilot testing was initially carried out with a convenience sample of seven patients in one cancer centre. The pilot study provided a number of valuable logistical insights, such as providing an accurate estimation of time required to complete data collection, and how best to manage the distribution and storage of each of the three copies of the consent forms (patient, medical record and research team copies). Only minor changes to the data collection instrument were made, however. The term ‘medical chart’ was replaced with ‘medical record’ as the latter was better understood by participants and data collectors. Also, adopting the practice of Woolery et al.,⁹ statements using lay terminology were used as clarifying descriptors for each Constipation Assessment Scale (CAS) item for any participants who did not understand the original CAS item.

Subsequently, data collection was carried out on a single day in each centre. It had been intended to carry out the study in all centres on the same day but operational issues meant that data was collected in two hospitals one week later.

A wide range of clinicians (consultants, specialist registrars, clinical nurse specialists, Advanced Nurse Practitioners, Assistant Directors of Nursing and Nurse Tutors) acted as data collectors for the study. All data collectors completed mandatory pre-study training comprising an e-learning presentation explaining how to follow the study protocol, carry out data collection and record data. A member of the research team was also present on the study day to oversee data collection and provide any additional support, as needed.

In-patients or patients attending day oncology wards were eligible to participate. Inclusion criteria were: (1) cancer diagnosis; (2) informed of diagnosis (3) aged ≥18 years; (4) English speaking. Exclusion criteria were: (1) surgery ≤24 hours prior to the study; (2) cognitive impairment or reduced level of consciousness; (3) patient deemed too unwell to participate by the clinician. The inclusion criteria and data collection methods were applied consistently across all study sites to reduce the potential for bias.

Data collection

Data collectors first liaised with clinical nurse managers of each ward in order to identify eligible patients and then approached the potential participant. The data collector provided both verbal and written information on the study to the patient and answered any questions that were asked. Following this, patients were invited to take part in the study on that day. Although a ‘cooling off’ period of one hour was offered, patients could waive that if desired.

Demographic details were collected (gender and age) and the Constipation Assessment Scale (CAS)¹⁰ completed¹¹. Respondents were shown the Bristol Stool Chart¹² and asked “Can you look at this scale and thinking of the last time you had your bowels open, which picture best resembles what it looked like?”. Two questions were asked about medications: ‘Are you currently taking medication prescribed by your doctor to manage your constipation?’ and ‘Are you currently taking medication that you purchased yourself to manage your constipation?’ Details on diagnosis, treatment and analgesics were extracted from chart review (see Extended data for a copy of the survey instrument¹³).

Analysis

Data were summarised using descriptive statistics. Significance of variations for continuous data were determined using t-tests.

Two outcomes were examined: 1) the Constipation Assessment Scale (CAS); and 2) laxative use.

1) Conditional ordered logistic regression was undertaken to determine factors associated with constipation. A categorical variable based on CAS scores was the dependent variable: no constipation (CAS score=0); mild constipation (CAS score 1–6) or severe constipation (CAS score 7–16). The independent variables were:

Age - categorised during data collection in accordance with requirements for ethical approval at study sites.
Gender- collected as a binary variable at the time of data collection.
Primary cancer site - grouped into nine categories according to site of origin
Currently receiving chemotherapy - binary variable.
Currently receiving radiotherapy - binary variable.
Currently using opioids - binary variable (Step 3 opioid use)
Currently utilising specialist palliative care services – binary variable
Laxative use - categorised into 4 groups capturing observed utilisation patterns: no use; using over-the counter only; using prescription only; using a combination prescription and over-the-counter laxatives.

2) Random effects logistic regression was undertaken to examine factors associated with laxative use. The binary dependent variable was laxative use (yes if taking any type of laxative). The independent variables were:

Age, gender, receiving chemotherapy, receiving radiotherapy, utilising specialist palliative care services and opioid use - these were handled in the same manner as described above
Additionally, the CAS score total was included as a continuous variable.

Analyses were carried out using Stata 15¹⁴, and tests of statistical significance were at p⩽0.05. In both models, odds ratios (OR) and 95% confidence intervals (CI) were estimated for each independent variable. All cases with incomplete data for the CAS items were excluded from regression analysis. Number of missing cases are shown in all relevant tables (Table 3 and Table 4).

Reporting was provided according to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) criteria¹⁵ (see Extended data for a copy of the completed STROBE checklist¹³).

Results

Participants

In total, 491 patients were recruited (Table 1); 51.5% were female and 46.2% were aged ≥65 years. Haematological, breast and genitourinary cancers were the most common diagnoses. 44.6% were attending Day Oncology or Haematology services, with the remainder receiving inpatient care. The Specialist Palliative Care team were providing care to 24.8%; 14.5% had input from the Anaesthetic Pain Team. Pain was reported by 62.5% and Step 2 or 3 analgesics were being used by 42%. Patients who were receiving Palliative Care or Pain team input were more likely to be taking step 2 or 3 analgesics than patients who were not receiving input (p<0.001).

Table 1. Participant characteristics.

	Frequency	Percentage
Gender: Male Female Missing	206 253 32	42.0 51.5 6.5
Age groups: 18-39 40-64 65-79 80+ Missing	43 216 191 36 5	8.7 44.1 39.0 7.3 1.0
Cancer Site: Haematological Breast Genitourinary Lung Lower Gastrointestinal Upper Gastrointestinal Neurological Other/Multiple sites Missing	117 77 64 49 49 43 9 63 20	23.8 15.7 13 9.8 9.8 8.8 1.8 12.8 4
Anti-tumour treatment: Receiving chemotherapy Not receiving chemotherapy Missing Receiving radiotherapy Not receiving radiotherapy Missing Had surgical intervention Did not have surgical intervention Missing	351 123 17 176 296 19 241 234 16	71.5 25.0 3.5 35.8 60.3 3.9 49.1 47.7 3.3
Laxative use: None Prescribed laxatives Over-the-counter laxatives (self-medicating) Both prescribed and over-the-counter laxatives Missing/ not applicable (stoma)	226 158 22 39 46	46 32.2 4.5 8.0 9.3
Specialist team involvement: Specialist palliative care (‘SPC’) involved in care SPC not involved in care Missing Specialist pain team (‘Pain team’) involved in care Pain team not involved in care Missing	122 339 30 71 371 49	24.9 69.0 6.1 14.5 75.6 10.0
Site of recruitment: Cancer centre 1 Cancer centre 2 Cancer centre 3 Cancer centre 4 Cancer centre 5 Cancer centre 6 Cancer centre 7 Cancer centre 8	32 50 27 64 89 91 95 43	6.5 10.2 5.5 13.0 18.1 18.5 19.4 8.8

Constipation Assessment Scale score

The prevalence of constipation among all participants was 67.6%, based on CAS criteria of a score of ≥1. Only 8.3% of respondents reported no symptoms while 19.4% of respondents scored ≥7, indicating severe constipation.

Most commonly reported symptoms were reduced bowel movements (44.8%), change in the amount of gas passed rectally (44.8%) and abdominal distension or bloating (43.4%). The symptoms affecting patients most severely were reduced bowel movements (14.7%), abdominal distension or bloating (12%) and rectal fullness or pressure (11.4%). Further detail is provided in Table 2.

Table 2. Constipation Assessment Scale scores.

Item	No problem	Some problem	Severe problem	Missing data*
Abdominal distension or bloating	268 (54.6%)	154 (31.4%)	59 (12%)	10 (2%)
Change in the amount of gas passed rectally	254 (51.7%)	168 (34.2%)	52 (10.6%)	17 (3.4%)
Less frequent bowel movements	250 (51.0%)	148 (30.1%)	72 (14.7%)	21 (4.2%)
Oozing liquid stool	349 (71.1%)	86 (17.5%)	33 (6.7%)	23 (4.7%)
Rectal fullness or pressure	312 (63.5%)	103 (21.0%)	56 (11.4%)	20 (4.1%)
Rectal pain with bowel movement	343 (69.9%)	85 (17.3%)	42 (8.6%)	21 (4.3%)
Smaller stool size	288 (58.7%)	134 (27.3%)	40 (8.2%)	29 (6.0%)
Urge, but inability to pass stool	287 (58.5%)	131 (26.7%)	55 (11.2%)	18 (3.6%)

*Missing data or not collected

Bristol Stool Chart

20.9% reported hard stools, 55.2% reported normal stools and 17.6% reported loose stools. A weak negative correlation (r =-0.1), was observed for CAS scores and stool type, indicating that lower CAS scores were associated with looser stool.

Laxative use

Just under half (46%) were not taking laxatives. 32.2% were taking prescribed laxatives. Some patients were self-medicating by taking over-the-counter laxatives- 4.5% were taking over-the-counter laxatives alone, while a further 8.0% were taking both prescribed laxatives and supplementary over-the-counter laxatives. Despite taking laxatives, 54.8% of participants reported symptoms.

Factors associated with constipation burden

Ordered logistic regression analysis was conducted to examine factors associated with constipation (Table 3). Female gender was associated with increased odds of reporting constipation burden (OR 1.975, 95% CI: 1.16-3.35; p= 0.012). Those aged 80 and over were less likely to be constipated than those aged 18–39 (OR .285, 95% CI: .082-.995; p=0.49). Neither treatment with chemotherapy nor radiotherapy were associated with higher CAS scores. Unsurprisingly, opioid use was strongly associated with higher CAS scores (OR 2.19, 95% CI:1.30-3.67; p=0.003). Importantly, no association between receiving SPC and increased constipation burden was noted (p=0.35). Patients who were constipated were more likely to be taking prescribed (OR 6.446, 95% CI: 3.43-12.15; p<.001), over-the-counter laxatives (OR 3.171, 95% CI: 1.064-9.450; p=0.04), or a combination of both (OR 21.957, 95% CI: 8.001-60.254; p<0.001).

Table 3. Ordered logistic regression examining factors associated with constipation burden.

Variable	Odds ratio	p-value	95% CI
Age category
*18–39*	REF
*40–64*	.491	0.103	.209	1.155
*65–79*	.455	0.082	.187	1.103
*>79*	.285	0.049	.082	.995
Cancer site
*Upper gastrointestinal*	REF
*Lower gastrointestinal*	.698	0.552	.213	2.286
*Genitourinary*	.430	0.130	.144	1.281
*Neurological*	.275	0.237	.032	2.338
*Haematological*	.376	0.050	.141	1.00
*Breast*	.456	0.147	.158	1.318
*Lung*	.281	0.029	.089	.880
*Other*	.387	0.110	.121	1.240
*Multiple*	.347	0.185	.072	1.65
Gender
*Male*	REF
*Female*	1.975	0.012	1.164	3.351
Receiving chemotherapy	.786	0.445	.424	1.457
Receiving radiotherapy	1.055	0.836	.636	1.751
Using opioids	2.189	0.003	1.304	3.672
Utilising specialist palliative care services	1.33	0.352	.728	2.440
Using laxatives
*Nothing*	REF
*Prescribed*	6.446	<0.001	3.430	12.114
*Over-the-counter*	3.171	0.038	1.064	9.450
*Prescribed and over-the-counter*	21.958	<0.001	8.001	60.254

Table 4. Random effects logistic regression examining factors associated with laxative use.

Variable	Odds ratio	p-value	95% CI
Age category
*18–39*	REF
*40–64*	.935	0.895	.344	2.543
*65–79*	2.149	0.140	.779	5.932
*>79*	1.098	0.899	.259	4.665
Gender
*Male*	REF
*Female*	.734	0.280	.418	1.287
Receiving chemotherapy	.759	0.426	.386	1.495
Receiving radiotherapy	.872	0.641	.489	1.552
Utilising specialist palliative care services	2.953	0.002	1.476	5.905
Using opioids	1.824	0.042	1.022	3.257
CAS score	1.51	<0.001	1.354	1.685

Factors associated with laxative use

Although 39.8% experienced symptoms and were not taking laxatives, there was evidence that increased CAS scores were associated with increased odds of using laxatives (OR 1.510, 95% CI: 1.354-1.685; p<0.001). Being known to SPC services (OR 2.952, 95% CI:1.476-5.905; p=0.002) and opioid use (OR 1.824, 95% CI: 1.022-3.256; p=0.042) were also associated with increased odds of using laxatives.

Discussion

Patients attending cancer centres in Ireland have a significant constipation symptom burden echoing other study findings and demonstrating little change over time^6–8. Symptom profile was similar to the original CAS validation study¹⁰. Female gender was associated with constipation, but opioid use, unsurprisingly, was most strongly associated.

A total of 39.8% of participants were not taking laxatives despite symptoms, and 54.8% remained constipated despite taking laxatives. This points to a need not only to encourage appropriate laxative use but also to improve prescribing. Patients known to Palliative Care might be expected to be at higher risk of constipation due to opioid use and complex symptomatology. However, an association between Palliative Care input and increased constipation burden was not observed. It is hypothesised that this is attributable to the fact that patients receiving Palliative Care benefitted from comprehensive symptom assessment and appropriate prescribing supported by guideline use.

Different countries have taken different approaches to the development of constipation guidelines¹⁶. In Ireland, the only national guideline on constipation is titled ‘Management of Constipation of Adult Patients Receiving Palliative Care’⁵. Acknowledging that misperceptions exist regarding the term ‘palliative care’¹⁷, and noting the high prevalence of constipation found in the broader cancer population studied, it is possible that the title acted as a barrier to uptake. Planning is key to successful guideline development¹⁸, and identification of scope a critical first step¹⁹. While it is possible to develop broad guidelines, considerable resources are required and influence decisions regarding scope. Given the lack of improvement seen to date, we suggest that a broader approach in future guidelines should be considered to reduce fragmentation of practice and build momentum in quality improvement.

Study limitations include the fact that patient experience outside cancer centres is not described. While the multi-site design adds to the robust nature of data collection, logistical challenges meant that the study was not carried out on a single day and centres demonstrated variability in recruitment. Finally, given the disparity of a single agreed definition for constipation, a potential confounder is chronic constipation as defined by ROME Diagnostic Criteria²⁰. Future studies should aim to characterise patients who have a pre-morbid diagnosis of chronic constipation.

Conclusion

Cancer-related constipation remains inadequately recognised and treated. The merits of symptom assessment and guideline application as evidenced by lower symptom burden associated with Palliative Care input are suggested. The confirmation of the high prevalence of constipation in the wider population, reaffirms the need to find more effective approaches to quality improvement across the cancer trajectory.

Data availability

Underlying data

Due to the nature of this research and the consent document, participants of this study were not asked to consent to the sharing of data beyond the research team and their collaborators. As a result, underlying data cannot be publicly provided. Researchers seeking to access the underlying dataset will need to apply directly to all University and Hospital Research Ethics Committees for approval. UCD Office of Research Ethics can be contacted at research.ethics@ucd.ie; the individual hospital research ethics committees can be contacted at beaumontethics@rcsi.com; colette.collins@hse.ie; caroline.lamb2@hse.ie; soneill@mater.ie; research@stjames.ie; svhgethics@ucd.ie; crec@ucc.ie; joanne.oconnor@hse.ie. Should approval be granted, the corresponding author is happy to facilitate access in circumstances where data are fully and irrevocably anonymised, where data are being accessed for the purposes of further research and where a data access agreement is signed that meets any and all requirements specified by the Lead University and Principal Investigator.

Extended data

Open Science Framework: Ryan K. National cross-sectional study of constipation in patients attending cancer centres. https://doi.org/10.17605/OSF.IO/ZXDSK¹³.

This project contains the following extended data:

- Strobe checklist Ryan National cross sectional study of constipation.pdf
- Survey Instruments Ryan National cross sectional study of constipation.pdf

Data are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).

Acknowledgements

We thank the patients and staff of the following hospitals for their participation and support of the study: Mater Misericordiae University Hospital, St Vincent’s University Hospital; Beaumont Hospital; St James’s University Hospital; Cork University Hospital; University Hospital Waterford; University Hospital Limerick; Galway University Hospital.

Faculty Opinions recommended

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Comments on this article Comments (1)

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Author Response 13 Dec 2021

Karen Ryan, University College Dublin, Dublin, D04 V1W8, Ireland

13 Dec 2021

Author Response

Dear Drs Candy and Wickham,
Many thanks for your considered reviews and helpful commentary. We will revise the manuscript accordingly and look forward to providing an improved draft in the ... Continue reading Dear Drs Candy and Wickham,
Many thanks for your considered reviews and helpful commentary. We will revise the manuscript accordingly and look forward to providing an improved draft in the near future. We appreciate the time that has been given to providing peer review.
Dear Drs Candy and Wickham,
Many thanks for your considered reviews and helpful commentary. We will revise the manuscript accordingly and look forward to providing an improved draft in the near future. We appreciate the time that has been given to providing peer review.
Competing Interests: Nil to declare Close
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Author details Author details

Karen Ryan
Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Bridget M. Johnston
Roles: Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Clare McAleer
Roles: Formal Analysis, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

This project was funded by a grant awarded to Prof. Laserina O’Connor and Prof. Philip Larkin from the Department of Health, Health Service Executive and Irish Cancer Society (01092016PCPPS).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (2)

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Revised

Published: 14 Jun 2022, 4:113

https://doi.org/10.12688/hrbopenres.13315.2

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Published: 15 Oct 2021, 4:113

https://doi.org/10.12688/hrbopenres.13315.1

© 2021 Ryan K et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Ryan K, Johnston BM, McAleer C et al. A national cross-sectional survey of constipation in patients attending cancer centres in Ireland [version 1; peer review: 2 approved with reservations]. HRB Open Res 2021, 4:113 (https://doi.org/10.12688/hrbopenres.13315.1)

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Reviewer Report 10 Dec 2021

Rita Wickham, Rush University College of Nursing, Chicago, IL, USA

Approved with Reservations

https://doi.org/10.21956/hrbopenres.14496.r30749

This is a well-written, clinically useful paper that I will look forward to reading in its final, edited form. There are minor editorial issues in punctuation that an editor will easily fix. My suggestions for improving this research report center ... Continue reading

The authors should include details of instruments. Demographic data includes more than age and gender and this is just a list. Need more information about the CAS and the Bristol Stool Chart (figure might be useful, given contention of under-assessment). For instance, the CAS is an easily understood patient-completed tool that evaluates eight potential manifestations of constipation rated on a 3-point scale (no problem, some problem, severe problem). It is scored ----- etc.. Psychometric data and info about use in other populations/translation would strengthen choice of tool (Doğan & Aktuğ (2017¹), Woolery et al. (2006²), Dal Molin et al. (2012³)).
Do the same for the Bristol Stool Chart (Amarenco G (2014⁴), Srinivas et al. (2019⁵)). These are just examples.
You state you identified patients taking opioid analgesics step 2 & 3, but page 4 mentions only step 3. Which did you actually include? Although most clinicians may be familiar with the ladder concept, some may not be. It may be useful to include a brief modifier, i.e. step 2 (codeine-like) and step 3 (morphine-like).
Another question I had was regarding what laxatives are OTC and which are prescription in Ireland. I don't know if these differ from my (and other) country.
Table 1: Do you want to call them participants, patients, or patient participants? Consider different layout for this table, with columns for yes (n/percent), no (n /%), and missing. Would be easier to read.
On page 5, report of CAS scores will make sense if information about the instrument is included in the earlier section.
Page 7: include the actual correlation coefficient before the p value.
I had a question about laxative use that you may or may not be able to address in the discussion section: do patients typically self-medicate with laxatives, or do health professionals recommend they start with OTC laxatives?
The last sentence in the first paragraph of the Discussion is confusing. Consider more direct: The factors most commonly associated with constipation in this sample of cancer patients receiving palliative care were opioid use and female sex (has this been previously found?): And how about stressing enhanced systematic constipation assessment.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

References

1. Melike Demir Doğan, Cemile Aktuğ: Validity And Reliability Of The Turkish Version Of Constipation Assessment Scale In Nursing Students. Euras J Fam Med. 2017; 6 (2): 72-76 Reference Source
2. Woolery M, Carroll E, Fenn E, Wieland H, et al.: A constipation assessment scale for use in pediatric oncology.J Pediatr Oncol Nurs. 23 (2): 65-74 PubMed Abstract | Publisher Full Text
3. Dal Molin A, McMillan SC, Zenerino F, Rattone V, et al.: Validity and reliability of the Italian Constipation Assessment Scale.Int J Palliat Nurs. 2012; 18 (7): 321-5 PubMed Abstract | Publisher Full Text
4. Amarenco G: [Bristol Stool Chart: Prospective and monocentric study of "stools introspection" in healthy subjects].Prog Urol. 2014; 24 (11): 708-13 PubMed Abstract | Publisher Full Text
5. Srinivas M, Srinivasan V, Jain M, Rani Shanthi CS, et al.: A cross-sectional study of stool form (using Bristol stool chart) in an urban South Indian population.JGH Open. 2019; 3 (6): 464-467 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: palliative care, symptom management

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 04 Jan 2023

Karen Ryan, University College Dublin, Dublin, D04 V1W8, Ireland

04 Jan 2023

Author Response

We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring ... Continue reading We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R2/ C1: The authors should include details of instruments. Demographic data includes more than age and gender and this is just a list. Need more information about the CAS and the Bristol Stool Chart (figure might be useful, given contention of under-assessment).
Response 1: Thank you for this helpful suggestion. We have amended the manuscript to include details on the CAS and Bristol Stool Chart as suggested (lines 147-155 and 159-166).

R2/ C2: Do the same for the Bristol Stool Chart
Response 2: We have amended the manuscript to include details of instruments as suggested in the Data Collection section (lines 159-166).

R2/ C3: You state you identified patients taking opioid analgesics step 2 & 3, but page 4 mentions only step 3. Which did you actually include? Although most clinicians may be familiar with the ladder concept, some may not be. It may be useful to include a brief modifier, i.e. step 2 (codeine-like) and step 3 (morphine-like).
Response 3: Thank you for noting this discrepancy. We identified patients taking both step 2 and 3 analgesics and have amended the sentence on line 193 in the Analysis section to include both of these groups. We have also included a modifier as suggested by the reviewer, identifying step 2 analgesics as ‘weak opioids’ and step 3 analgesics as ‘strong opioids’.

R2/ C4: Another question I had was regarding what laxatives are OTC and which are prescription in Ireland. I don't know if these differ from my (and other) country.
Response 4: We are grateful for this prompt to improve the international readability of the manuscript and have included explanatory content in the Discussion (lines 302-309).

R2/ C5: Table 1: Do you want to call them participants, patients, or patient participants? Consider different layout for this table, with columns for yes (n/percent), no (n /%), and missing. Would be easier to read.
Response 5: We agree with the importance of consistent terminology and have amended the manuscript to consistently use the term ‘patient participants’. While we appreciate the reviewer’s feedback with regards to the layout of Table 1, we are unfortunately unable to organise all data presented in this table into ‘yes/ no’ categories and so were unable to adopt this suggestion.

R2/C6: On page 5, report of CAS scores will make sense if information about the instrument is included in the earlier section.
Response 6: Thank you. The information has been included as suggested (lines 147-155) in the Data Collection section.

R2/ C7: Page 7: include the actual correlation coefficient before the p value.
Response 7: Thank you for noting this. We have amended the manuscript to include the correlation coefficient in the paragraph on Factors Associated with Constipation Burden (line 273).

R2/ C8: I had a question about laxative use that you may or may not be able to address in the discussion section: do patients typically self-medicate with laxatives, or do health professionals recommend they start with OTC laxatives?
Response 8: We have now incorporated additional information regarding self-medication practice in Ireland and an accompanying reference to lines 301-308 of the Discussion.

R2/ C9: The last sentence in the first paragraph of the Discussion is confusing. Consider more direct: The factors most commonly associated with constipation in this sample of cancer patients receiving palliative care were opioid use and female sex (has this been previously found?): And how about stressing enhanced systematic constipation assessment.
Response 9: We have amended the wording of the first paragraph of the Discussion as suggested to avoid confusion in presentation with data and to include reference to the general literature (lines 290-299). The importance of systematic constipation assessment has been highlighted (lines 333-334).
We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R2/ C1: The authors should include details of instruments. Demographic data includes more than age and gender and this is just a list. Need more information about the CAS and the Bristol Stool Chart (figure might be useful, given contention of under-assessment).
Response 1: Thank you for this helpful suggestion. We have amended the manuscript to include details on the CAS and Bristol Stool Chart as suggested (lines 147-155 and 159-166).

R2/ C2: Do the same for the Bristol Stool Chart
Response 2: We have amended the manuscript to include details of instruments as suggested in the Data Collection section (lines 159-166).

R2/ C3: You state you identified patients taking opioid analgesics step 2 & 3, but page 4 mentions only step 3. Which did you actually include? Although most clinicians may be familiar with the ladder concept, some may not be. It may be useful to include a brief modifier, i.e. step 2 (codeine-like) and step 3 (morphine-like).
Response 3: Thank you for noting this discrepancy. We identified patients taking both step 2 and 3 analgesics and have amended the sentence on line 193 in the Analysis section to include both of these groups. We have also included a modifier as suggested by the reviewer, identifying step 2 analgesics as ‘weak opioids’ and step 3 analgesics as ‘strong opioids’.

R2/ C4: Another question I had was regarding what laxatives are OTC and which are prescription in Ireland. I don't know if these differ from my (and other) country.
Response 4: We are grateful for this prompt to improve the international readability of the manuscript and have included explanatory content in the Discussion (lines 302-309).

R2/ C5: Table 1: Do you want to call them participants, patients, or patient participants? Consider different layout for this table, with columns for yes (n/percent), no (n /%), and missing. Would be easier to read.
Response 5: We agree with the importance of consistent terminology and have amended the manuscript to consistently use the term ‘patient participants’. While we appreciate the reviewer’s feedback with regards to the layout of Table 1, we are unfortunately unable to organise all data presented in this table into ‘yes/ no’ categories and so were unable to adopt this suggestion.

R2/C6: On page 5, report of CAS scores will make sense if information about the instrument is included in the earlier section.
Response 6: Thank you. The information has been included as suggested (lines 147-155) in the Data Collection section.

R2/ C7: Page 7: include the actual correlation coefficient before the p value.
Response 7: Thank you for noting this. We have amended the manuscript to include the correlation coefficient in the paragraph on Factors Associated with Constipation Burden (line 273).

R2/ C8: I had a question about laxative use that you may or may not be able to address in the discussion section: do patients typically self-medicate with laxatives, or do health professionals recommend they start with OTC laxatives?
Response 8: We have now incorporated additional information regarding self-medication practice in Ireland and an accompanying reference to lines 301-308 of the Discussion.

R2/ C9: The last sentence in the first paragraph of the Discussion is confusing. Consider more direct: The factors most commonly associated with constipation in this sample of cancer patients receiving palliative care were opioid use and female sex (has this been previously found?): And how about stressing enhanced systematic constipation assessment.
Response 9: We have amended the wording of the first paragraph of the Discussion as suggested to avoid confusion in presentation with data and to include reference to the general literature (lines 290-299). The importance of systematic constipation assessment has been highlighted (lines 333-334).
Competing Interests: No competing interests to disclose Close
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COMMENTS ON THIS REPORT

Author Response 04 Jan 2023

Karen Ryan, University College Dublin, Dublin, D04 V1W8, Ireland

04 Jan 2023

Author Response

We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring ... Continue reading We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R2/ C1: The authors should include details of instruments. Demographic data includes more than age and gender and this is just a list. Need more information about the CAS and the Bristol Stool Chart (figure might be useful, given contention of under-assessment).
Response 1: Thank you for this helpful suggestion. We have amended the manuscript to include details on the CAS and Bristol Stool Chart as suggested (lines 147-155 and 159-166).

R2/ C2: Do the same for the Bristol Stool Chart
Response 2: We have amended the manuscript to include details of instruments as suggested in the Data Collection section (lines 159-166).

R2/ C3: You state you identified patients taking opioid analgesics step 2 & 3, but page 4 mentions only step 3. Which did you actually include? Although most clinicians may be familiar with the ladder concept, some may not be. It may be useful to include a brief modifier, i.e. step 2 (codeine-like) and step 3 (morphine-like).
Response 3: Thank you for noting this discrepancy. We identified patients taking both step 2 and 3 analgesics and have amended the sentence on line 193 in the Analysis section to include both of these groups. We have also included a modifier as suggested by the reviewer, identifying step 2 analgesics as ‘weak opioids’ and step 3 analgesics as ‘strong opioids’.

R2/ C4: Another question I had was regarding what laxatives are OTC and which are prescription in Ireland. I don't know if these differ from my (and other) country.
Response 4: We are grateful for this prompt to improve the international readability of the manuscript and have included explanatory content in the Discussion (lines 302-309).

R2/ C5: Table 1: Do you want to call them participants, patients, or patient participants? Consider different layout for this table, with columns for yes (n/percent), no (n /%), and missing. Would be easier to read.
Response 5: We agree with the importance of consistent terminology and have amended the manuscript to consistently use the term ‘patient participants’. While we appreciate the reviewer’s feedback with regards to the layout of Table 1, we are unfortunately unable to organise all data presented in this table into ‘yes/ no’ categories and so were unable to adopt this suggestion.

R2/C6: On page 5, report of CAS scores will make sense if information about the instrument is included in the earlier section.
Response 6: Thank you. The information has been included as suggested (lines 147-155) in the Data Collection section.

R2/ C7: Page 7: include the actual correlation coefficient before the p value.
Response 7: Thank you for noting this. We have amended the manuscript to include the correlation coefficient in the paragraph on Factors Associated with Constipation Burden (line 273).

R2/ C8: I had a question about laxative use that you may or may not be able to address in the discussion section: do patients typically self-medicate with laxatives, or do health professionals recommend they start with OTC laxatives?
Response 8: We have now incorporated additional information regarding self-medication practice in Ireland and an accompanying reference to lines 301-308 of the Discussion.

R2/ C9: The last sentence in the first paragraph of the Discussion is confusing. Consider more direct: The factors most commonly associated with constipation in this sample of cancer patients receiving palliative care were opioid use and female sex (has this been previously found?): And how about stressing enhanced systematic constipation assessment.
Response 9: We have amended the wording of the first paragraph of the Discussion as suggested to avoid confusion in presentation with data and to include reference to the general literature (lines 290-299). The importance of systematic constipation assessment has been highlighted (lines 333-334).
We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R2/ C1: The authors should include details of instruments. Demographic data includes more than age and gender and this is just a list. Need more information about the CAS and the Bristol Stool Chart (figure might be useful, given contention of under-assessment).
Response 1: Thank you for this helpful suggestion. We have amended the manuscript to include details on the CAS and Bristol Stool Chart as suggested (lines 147-155 and 159-166).

R2/ C2: Do the same for the Bristol Stool Chart
Response 2: We have amended the manuscript to include details of instruments as suggested in the Data Collection section (lines 159-166).

R2/ C3: You state you identified patients taking opioid analgesics step 2 & 3, but page 4 mentions only step 3. Which did you actually include? Although most clinicians may be familiar with the ladder concept, some may not be. It may be useful to include a brief modifier, i.e. step 2 (codeine-like) and step 3 (morphine-like).
Response 3: Thank you for noting this discrepancy. We identified patients taking both step 2 and 3 analgesics and have amended the sentence on line 193 in the Analysis section to include both of these groups. We have also included a modifier as suggested by the reviewer, identifying step 2 analgesics as ‘weak opioids’ and step 3 analgesics as ‘strong opioids’.

R2/ C4: Another question I had was regarding what laxatives are OTC and which are prescription in Ireland. I don't know if these differ from my (and other) country.
Response 4: We are grateful for this prompt to improve the international readability of the manuscript and have included explanatory content in the Discussion (lines 302-309).

R2/ C5: Table 1: Do you want to call them participants, patients, or patient participants? Consider different layout for this table, with columns for yes (n/percent), no (n /%), and missing. Would be easier to read.
Response 5: We agree with the importance of consistent terminology and have amended the manuscript to consistently use the term ‘patient participants’. While we appreciate the reviewer’s feedback with regards to the layout of Table 1, we are unfortunately unable to organise all data presented in this table into ‘yes/ no’ categories and so were unable to adopt this suggestion.

R2/C6: On page 5, report of CAS scores will make sense if information about the instrument is included in the earlier section.
Response 6: Thank you. The information has been included as suggested (lines 147-155) in the Data Collection section.

R2/ C7: Page 7: include the actual correlation coefficient before the p value.
Response 7: Thank you for noting this. We have amended the manuscript to include the correlation coefficient in the paragraph on Factors Associated with Constipation Burden (line 273).

R2/ C8: I had a question about laxative use that you may or may not be able to address in the discussion section: do patients typically self-medicate with laxatives, or do health professionals recommend they start with OTC laxatives?
Response 8: We have now incorporated additional information regarding self-medication practice in Ireland and an accompanying reference to lines 301-308 of the Discussion.

R2/ C9: The last sentence in the first paragraph of the Discussion is confusing. Consider more direct: The factors most commonly associated with constipation in this sample of cancer patients receiving palliative care were opioid use and female sex (has this been previously found?): And how about stressing enhanced systematic constipation assessment.
Response 9: We have amended the wording of the first paragraph of the Discussion as suggested to avoid confusion in presentation with data and to include reference to the general literature (lines 290-299). The importance of systematic constipation assessment has been highlighted (lines 333-334).
Competing Interests: No competing interests to disclose Close
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Reviewer Report 06 Dec 2021

Bridget Candy, Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK

Approved with Reservations

https://doi.org/10.21956/hrbopenres.14496.r30752

This national survey provides prevalence rate of constipation for people attending cancer centres in Ireland. It finds a high prevalence of constipation, and limited use of laxations. The authors recommend better prescribing supported by clinical guidelines.

To make the article suitable for publication I would recommend some tightening in the writing, there are some redundant words and lack of order/flow between sections. The authors interchange between palliative care and Palliative Care. The results presentation does not follow the order set out in methods, as in first prevalence and then severity and then management. If they follow this in the abstract, results and then in brief in the discussion it will make the paper clearer.

Abstract and introduction: It would be expected for the introduction to include what was said in the abstract background but to say it in more detail. For example, why are prevalence estimates so wide (50 to 90%). Also to set this in context what is the prevalence of constipation in the general population.
Method:
- They use fairly old data – you need to mention this in the discussion.
- Helpful for readers to know more on the Bristol Stool Chart, as in number of items and what the items are.
- I note there is limited/no data collection on opioid intake, cancer severity, and ethnicity/cultural difference. All these factors will effect constipation/how patient manages constipation.
Results:
- The authors need to give the reader some indication of how representative the 491 patients were of all such patients in Ireland. Also what about refusal rate?
- Participant characteristics – you have not detailed whether prevalence differs between in and out-patients.
- Table 1 – it is not that informative to give detail as stated on cancer centre recruitment. For instance, why is there a range of recruitment rates. Is it the case that the larger centres provided more participants?
Discussion: Is this the first national survey in Ireland or even elsewhere – if so say so. They refer to your findings echoing other studies, it would be helpful if they could say whether these studies were in Ireland or elsewhere.
Conclusion: Add Ireland to the first sentence.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

I cannot comment. A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?

No source data required
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: I am a palliative care researcher who has undertaken research in the treatment of opioid induced constipation

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Author Response 04 Jan 2023

Karen Ryan, University College Dublin, Dublin, D04 V1W8, Ireland

04 Jan 2023

Author Response

We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring ... Continue reading We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R1/ C1: To make the article suitable for publication I would recommend some tightening in the writing, there are some redundant words and lack of order/flow between sections. The authors interchange between palliative care and Palliative Care. The results presentation does not follow the order set out in methods, as in first prevalence and then severity and then management. If they follow this in the abstract, results and then in brief in the discussion it will make the paper clearer.
Reponse 1: Thank you. We have edited the manuscript according to suggestions by ensuring consistency of terminology, and by making changes to improve the flow and order of narrative (lines 219-221; 302-305; 313-317; 368). We have ordered the presentation of results as recommended (lines 228-250).

R1/ C2: It would be expected for the introduction to include what was said in the abstract background but to say it in more detail. For example, why are prevalence estimates so wide (50 to 90%). Also to set this in context what is the prevalence of constipation in the general population.
Reponse 2: We have incorporated suggested amendments in the Introduction by providing additional detail on the study context, prevalence of both constipation and cancer-related constipation in the population and also included greater detail on the impact of the condition on individual patients and society. The specific edits can be found at: lines 58-60; 62-67 (additional detail on prevalence and burden); 70-77 (additional detail on context).

R1/ C3: They use fairly old data – you need to mention this in the discussion.
Response 3: The year of data collection is stated in the Methods section (study design and subjects), but we agree that this would also form a useful part of the Discussion section in line with the reviewer’s commentary. Accordingly, we have added a line discussing this to the paragraph on study limitations in the DIscussion (lines 351,352)

R1/ C4: Helpful for readers to know more on the Bristol Stool Chart, as in number of items and what the items are.
Response 4: We have provided additional content on both the Bristol Stool Chart and the Constipation Assessment Scale in the second and third paragraphs of the Data Collection section (lines 147-155 and 159-166)

R1/ C5: I note there is limited/no data collection on opioid intake, cancer severity, and ethnicity/cultural difference. All these factors will effect constipation/how patient manages constipation

Response 5: Thank you; we agree that further exploration of these factors would be of interest. In our study the selection of data items for collection was based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. We acknowledge that trade-offs are an integral part of making decisions about what data to collect and that it is important to point to limitations associated with data collection choices. We have therefore added content responding to the reviewer’s observations to the paragraph on study limitations in the Discussion (lines 352-360).

R1/ C6: The authors need to give the reader some indication of how representative the 491 patients were of all such patients in Ireland. Also what about refusal rate? Participant characteristics – you have not detailed whether prevalence differs between in and out-patients. Table 1 – it is not that informative to give detail as stated on cancer centre recruitment. For instance, why is there a range of recruitment rates. Is it the case that the larger centres provided more participants?
Response 6: Thank you for noting this; we agree that a greater understanding of representativeness of the sample would be of value, we are unfortunately unable to provide this information as census data on attendance at cancer centres in Ireland is not routinely collected. Decisions regarding data collection were based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. In particular, our study was conducted at a time of changing data protection laws in Ireland and gatekeeper concerns regarding the requirement for explicit consent for data processing resulted in restrictions on data collection being applied. As familiarity and experience with enactment of GDPR has grown in the intervening period, it would be expected that it would be possible to collect this data in future studies. We have added discussion of these limitations at lines 337-346 of the Discussion.

R1/ C7: Is this the first national survey in Ireland or even elsewhere – if so say so. They refer to your findings echoing other studies, it would be helpful if they could say whether these studies were in Ireland or elsewhere.
Response 7: This is the first national survey of constipation in patients attending cancer centres in Ireland, and to our knowledge, elsewhere. In response to the reviewer’s comments, we have included this detail and additional detail on other cited studies to help the reader better understand context of studies and comparability (lines 291-300) in the Discussion.

R1/ C8: Add Ireland to the first sentence.
Response 8: The manuscript has been amended to add this (line 366).
We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R1/ C1: To make the article suitable for publication I would recommend some tightening in the writing, there are some redundant words and lack of order/flow between sections. The authors interchange between palliative care and Palliative Care. The results presentation does not follow the order set out in methods, as in first prevalence and then severity and then management. If they follow this in the abstract, results and then in brief in the discussion it will make the paper clearer.
Reponse 1: Thank you. We have edited the manuscript according to suggestions by ensuring consistency of terminology, and by making changes to improve the flow and order of narrative (lines 219-221; 302-305; 313-317; 368). We have ordered the presentation of results as recommended (lines 228-250).

R1/ C2: It would be expected for the introduction to include what was said in the abstract background but to say it in more detail. For example, why are prevalence estimates so wide (50 to 90%). Also to set this in context what is the prevalence of constipation in the general population.
Reponse 2: We have incorporated suggested amendments in the Introduction by providing additional detail on the study context, prevalence of both constipation and cancer-related constipation in the population and also included greater detail on the impact of the condition on individual patients and society. The specific edits can be found at: lines 58-60; 62-67 (additional detail on prevalence and burden); 70-77 (additional detail on context).

R1/ C3: They use fairly old data – you need to mention this in the discussion.
Response 3: The year of data collection is stated in the Methods section (study design and subjects), but we agree that this would also form a useful part of the Discussion section in line with the reviewer’s commentary. Accordingly, we have added a line discussing this to the paragraph on study limitations in the DIscussion (lines 351,352)

R1/ C4: Helpful for readers to know more on the Bristol Stool Chart, as in number of items and what the items are.
Response 4: We have provided additional content on both the Bristol Stool Chart and the Constipation Assessment Scale in the second and third paragraphs of the Data Collection section (lines 147-155 and 159-166)

R1/ C5: I note there is limited/no data collection on opioid intake, cancer severity, and ethnicity/cultural difference. All these factors will effect constipation/how patient manages constipation

Response 5: Thank you; we agree that further exploration of these factors would be of interest. In our study the selection of data items for collection was based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. We acknowledge that trade-offs are an integral part of making decisions about what data to collect and that it is important to point to limitations associated with data collection choices. We have therefore added content responding to the reviewer’s observations to the paragraph on study limitations in the Discussion (lines 352-360).

R1/ C6: The authors need to give the reader some indication of how representative the 491 patients were of all such patients in Ireland. Also what about refusal rate? Participant characteristics – you have not detailed whether prevalence differs between in and out-patients. Table 1 – it is not that informative to give detail as stated on cancer centre recruitment. For instance, why is there a range of recruitment rates. Is it the case that the larger centres provided more participants?
Response 6: Thank you for noting this; we agree that a greater understanding of representativeness of the sample would be of value, we are unfortunately unable to provide this information as census data on attendance at cancer centres in Ireland is not routinely collected. Decisions regarding data collection were based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. In particular, our study was conducted at a time of changing data protection laws in Ireland and gatekeeper concerns regarding the requirement for explicit consent for data processing resulted in restrictions on data collection being applied. As familiarity and experience with enactment of GDPR has grown in the intervening period, it would be expected that it would be possible to collect this data in future studies. We have added discussion of these limitations at lines 337-346 of the Discussion.

R1/ C7: Is this the first national survey in Ireland or even elsewhere – if so say so. They refer to your findings echoing other studies, it would be helpful if they could say whether these studies were in Ireland or elsewhere.
Response 7: This is the first national survey of constipation in patients attending cancer centres in Ireland, and to our knowledge, elsewhere. In response to the reviewer’s comments, we have included this detail and additional detail on other cited studies to help the reader better understand context of studies and comparability (lines 291-300) in the Discussion.

R1/ C8: Add Ireland to the first sentence.
Response 8: The manuscript has been amended to add this (line 366).
Competing Interests: No competing interests to disclose Close
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COMMENTS ON THIS REPORT

Author Response 04 Jan 2023

Karen Ryan, University College Dublin, Dublin, D04 V1W8, Ireland

04 Jan 2023

Author Response

We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring ... Continue reading We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R1/ C1: To make the article suitable for publication I would recommend some tightening in the writing, there are some redundant words and lack of order/flow between sections. The authors interchange between palliative care and Palliative Care. The results presentation does not follow the order set out in methods, as in first prevalence and then severity and then management. If they follow this in the abstract, results and then in brief in the discussion it will make the paper clearer.
Reponse 1: Thank you. We have edited the manuscript according to suggestions by ensuring consistency of terminology, and by making changes to improve the flow and order of narrative (lines 219-221; 302-305; 313-317; 368). We have ordered the presentation of results as recommended (lines 228-250).

R1/ C2: It would be expected for the introduction to include what was said in the abstract background but to say it in more detail. For example, why are prevalence estimates so wide (50 to 90%). Also to set this in context what is the prevalence of constipation in the general population.
Reponse 2: We have incorporated suggested amendments in the Introduction by providing additional detail on the study context, prevalence of both constipation and cancer-related constipation in the population and also included greater detail on the impact of the condition on individual patients and society. The specific edits can be found at: lines 58-60; 62-67 (additional detail on prevalence and burden); 70-77 (additional detail on context).

R1/ C3: They use fairly old data – you need to mention this in the discussion.
Response 3: The year of data collection is stated in the Methods section (study design and subjects), but we agree that this would also form a useful part of the Discussion section in line with the reviewer’s commentary. Accordingly, we have added a line discussing this to the paragraph on study limitations in the DIscussion (lines 351,352)

R1/ C4: Helpful for readers to know more on the Bristol Stool Chart, as in number of items and what the items are.
Response 4: We have provided additional content on both the Bristol Stool Chart and the Constipation Assessment Scale in the second and third paragraphs of the Data Collection section (lines 147-155 and 159-166)

R1/ C5: I note there is limited/no data collection on opioid intake, cancer severity, and ethnicity/cultural difference. All these factors will effect constipation/how patient manages constipation

Response 5: Thank you; we agree that further exploration of these factors would be of interest. In our study the selection of data items for collection was based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. We acknowledge that trade-offs are an integral part of making decisions about what data to collect and that it is important to point to limitations associated with data collection choices. We have therefore added content responding to the reviewer’s observations to the paragraph on study limitations in the Discussion (lines 352-360).

R1/ C6: The authors need to give the reader some indication of how representative the 491 patients were of all such patients in Ireland. Also what about refusal rate? Participant characteristics – you have not detailed whether prevalence differs between in and out-patients. Table 1 – it is not that informative to give detail as stated on cancer centre recruitment. For instance, why is there a range of recruitment rates. Is it the case that the larger centres provided more participants?
Response 6: Thank you for noting this; we agree that a greater understanding of representativeness of the sample would be of value, we are unfortunately unable to provide this information as census data on attendance at cancer centres in Ireland is not routinely collected. Decisions regarding data collection were based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. In particular, our study was conducted at a time of changing data protection laws in Ireland and gatekeeper concerns regarding the requirement for explicit consent for data processing resulted in restrictions on data collection being applied. As familiarity and experience with enactment of GDPR has grown in the intervening period, it would be expected that it would be possible to collect this data in future studies. We have added discussion of these limitations at lines 337-346 of the Discussion.

R1/ C7: Is this the first national survey in Ireland or even elsewhere – if so say so. They refer to your findings echoing other studies, it would be helpful if they could say whether these studies were in Ireland or elsewhere.
Response 7: This is the first national survey of constipation in patients attending cancer centres in Ireland, and to our knowledge, elsewhere. In response to the reviewer’s comments, we have included this detail and additional detail on other cited studies to help the reader better understand context of studies and comparability (lines 291-300) in the Discussion.

R1/ C8: Add Ireland to the first sentence.
Response 8: The manuscript has been amended to add this (line 366).
We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R1/ C1: To make the article suitable for publication I would recommend some tightening in the writing, there are some redundant words and lack of order/flow between sections. The authors interchange between palliative care and Palliative Care. The results presentation does not follow the order set out in methods, as in first prevalence and then severity and then management. If they follow this in the abstract, results and then in brief in the discussion it will make the paper clearer.
Reponse 1: Thank you. We have edited the manuscript according to suggestions by ensuring consistency of terminology, and by making changes to improve the flow and order of narrative (lines 219-221; 302-305; 313-317; 368). We have ordered the presentation of results as recommended (lines 228-250).

R1/ C2: It would be expected for the introduction to include what was said in the abstract background but to say it in more detail. For example, why are prevalence estimates so wide (50 to 90%). Also to set this in context what is the prevalence of constipation in the general population.
Reponse 2: We have incorporated suggested amendments in the Introduction by providing additional detail on the study context, prevalence of both constipation and cancer-related constipation in the population and also included greater detail on the impact of the condition on individual patients and society. The specific edits can be found at: lines 58-60; 62-67 (additional detail on prevalence and burden); 70-77 (additional detail on context).

R1/ C3: They use fairly old data – you need to mention this in the discussion.
Response 3: The year of data collection is stated in the Methods section (study design and subjects), but we agree that this would also form a useful part of the Discussion section in line with the reviewer’s commentary. Accordingly, we have added a line discussing this to the paragraph on study limitations in the DIscussion (lines 351,352)

R1/ C4: Helpful for readers to know more on the Bristol Stool Chart, as in number of items and what the items are.
Response 4: We have provided additional content on both the Bristol Stool Chart and the Constipation Assessment Scale in the second and third paragraphs of the Data Collection section (lines 147-155 and 159-166)

R1/ C5: I note there is limited/no data collection on opioid intake, cancer severity, and ethnicity/cultural difference. All these factors will effect constipation/how patient manages constipation

Response 5: Thank you; we agree that further exploration of these factors would be of interest. In our study the selection of data items for collection was based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. We acknowledge that trade-offs are an integral part of making decisions about what data to collect and that it is important to point to limitations associated with data collection choices. We have therefore added content responding to the reviewer’s observations to the paragraph on study limitations in the Discussion (lines 352-360).

R1/ C6: The authors need to give the reader some indication of how representative the 491 patients were of all such patients in Ireland. Also what about refusal rate? Participant characteristics – you have not detailed whether prevalence differs between in and out-patients. Table 1 – it is not that informative to give detail as stated on cancer centre recruitment. For instance, why is there a range of recruitment rates. Is it the case that the larger centres provided more participants?
Response 6: Thank you for noting this; we agree that a greater understanding of representativeness of the sample would be of value, we are unfortunately unable to provide this information as census data on attendance at cancer centres in Ireland is not routinely collected. Decisions regarding data collection were based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. In particular, our study was conducted at a time of changing data protection laws in Ireland and gatekeeper concerns regarding the requirement for explicit consent for data processing resulted in restrictions on data collection being applied. As familiarity and experience with enactment of GDPR has grown in the intervening period, it would be expected that it would be possible to collect this data in future studies. We have added discussion of these limitations at lines 337-346 of the Discussion.

R1/ C7: Is this the first national survey in Ireland or even elsewhere – if so say so. They refer to your findings echoing other studies, it would be helpful if they could say whether these studies were in Ireland or elsewhere.
Response 7: This is the first national survey of constipation in patients attending cancer centres in Ireland, and to our knowledge, elsewhere. In response to the reviewer’s comments, we have included this detail and additional detail on other cited studies to help the reader better understand context of studies and comparability (lines 291-300) in the Discussion.

R1/ C8: Add Ireland to the first sentence.
Response 8: The manuscript has been amended to add this (line 366).
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VERSION 1 PUBLISHED 15 Oct 2021

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Author Response 13 Dec 2021

Karen Ryan, University College Dublin, Dublin, D04 V1W8, Ireland

13 Dec 2021

Author Response

Dear Drs Candy and Wickham,
Many thanks for your considered reviews and helpful commentary. We will revise the manuscript accordingly and look forward to providing an improved draft in the ... Continue reading Dear Drs Candy and Wickham,
Many thanks for your considered reviews and helpful commentary. We will revise the manuscript accordingly and look forward to providing an improved draft in the near future. We appreciate the time that has been given to providing peer review.
Dear Drs Candy and Wickham,
Many thanks for your considered reviews and helpful commentary. We will revise the manuscript accordingly and look forward to providing an improved draft in the near future. We appreciate the time that has been given to providing peer review.
Competing Interests: Nil to declare Close
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Bridget Candy, University College London, London, UK
Rita Wickham, Rush University College of Nursing, Chicago, USA
Young D. Chang, Moffitt Cancer Center, Tampa, USA

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Reviewer Report

23 Views

19 Oct 2022 | for Version 2

Young D. Chang, Department of Supportive Care Medicine, Moffitt Cancer Center, Tampa, FL, USA

23 Views Cite this report Responses(0)

Approved

Thank you for inviting me to review your article. This is a national cross-sectional study with a direct survey among 491 patients attending multi-designated Irish cancer centers to assess prevalence, severity, and management efficacy of constipation in cancer patients. The study showed again high prevalence (67.6%) of constipation among cancer patients. Female and opioid use were associated with higher constipation related symptom burden, but not patients under the management of palliative care specialists although constipation is generally expected more common and serious with high complex symptom burden. Interestingly, higher symptom burden with high CAS scores, opioid use and palliative care specialists were associated with laxative use. It is suggesting that palliative care may be an efficient way of the management for complex cancer related symptoms.

My impression was that it was well written and also straightforward study design. I would just suggest some minor issues.

I know that you indicated what SPC stands for. But, in the sentence of "being known to SPC services" in result section. It would be better to add " Specialist palliative care (SPC) in the main manuscript to avoid confusion for readers.
I am curious what are the differences between 'prescribed' vs 'OTC' in terms of chosen agent, dosage etc. OR was much higher with prescribed + OTC than prescribed and OTC.

Is the work clearly and accurately presented and does it cite the current literature?

Yes
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Cancer related pain and fatigue

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report

28 Views

21 Jun 2022 | for Version 2

Bridget Candy, Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK

28 Views Cite this report Responses(1)

Approved

I am happy with the revisions made and have no new comments on the revised article version.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

I am a palliative care researcher who has undertaken research in the treatment of opioid induced constipation

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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Reviewer Report

68 Views

10 Dec 2021 | for Version 1

Rita Wickham, Rush University College of Nursing, Chicago, IL, USA

68 Views Cite this report Responses(1)

Approved With Reservations

The authors should include details of instruments. Demographic data includes more than age and gender and this is just a list. Need more information about the CAS and the Bristol Stool Chart (figure might be useful, given contention of under-assessment). For instance, the CAS is an easily understood patient-completed tool that evaluates eight potential manifestations of constipation rated on a 3-point scale (no problem, some problem, severe problem). It is scored ----- etc.. Psychometric data and info about use in other populations/translation would strengthen choice of tool (Doğan & Aktuğ (2017¹), Woolery et al. (2006²), Dal Molin et al. (2012³)).
Do the same for the Bristol Stool Chart (Amarenco G (2014⁴), Srinivas et al. (2019⁵)). These are just examples.
You state you identified patients taking opioid analgesics step 2 & 3, but page 4 mentions only step 3. Which did you actually include? Although most clinicians may be familiar with the ladder concept, some may not be. It may be useful to include a brief modifier, i.e. step 2 (codeine-like) and step 3 (morphine-like).
Another question I had was regarding what laxatives are OTC and which are prescription in Ireland. I don't know if these differ from my (and other) country.
Table 1: Do you want to call them participants, patients, or patient participants? Consider different layout for this table, with columns for yes (n/percent), no (n /%), and missing. Would be easier to read.
On page 5, report of CAS scores will make sense if information about the instrument is included in the earlier section.
Page 7: include the actual correlation coefficient before the p value.
I had a question about laxative use that you may or may not be able to address in the discussion section: do patients typically self-medicate with laxatives, or do health professionals recommend they start with OTC laxatives?
The last sentence in the first paragraph of the Discussion is confusing. Consider more direct: The factors most commonly associated with constipation in this sample of cancer patients receiving palliative care were opioid use and female sex (has this been previously found?): And how about stressing enhanced systematic constipation assessment.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

No
If applicable, is the statistical analysis and its interpretation appropriate?

Yes
Are all the source data underlying the results available to ensure full reproducibility?

Yes
Are the conclusions drawn adequately supported by the results?

Yes

References

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

palliative care, symptom management

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Author Response

04 Jan 2023

Karen Ryan, University College Dublin, Dublin, D04 V1W8, Ireland

We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R2/ C1: The authors should include details of instruments. Demographic data includes more than age and gender and this is just a list. Need more information about the CAS and the Bristol Stool Chart (figure might be useful, given contention of under-assessment).
Response 1: Thank you for this helpful suggestion. We have amended the manuscript to include details on the CAS and Bristol Stool Chart as suggested (lines 147-155 and 159-166).

R2/ C2: Do the same for the Bristol Stool Chart
Response 2: We have amended the manuscript to include details of instruments as suggested in the Data Collection section (lines 159-166).

R2/ C3: You state you identified patients taking opioid analgesics step 2 & 3, but page 4 mentions only step 3. Which did you actually include? Although most clinicians may be familiar with the ladder concept, some may not be. It may be useful to include a brief modifier, i.e. step 2 (codeine-like) and step 3 (morphine-like).
Response 3: Thank you for noting this discrepancy. We identified patients taking both step 2 and 3 analgesics and have amended the sentence on line 193 in the Analysis section to include both of these groups. We have also included a modifier as suggested by the reviewer, identifying step 2 analgesics as ‘weak opioids’ and step 3 analgesics as ‘strong opioids’.

R2/ C4: Another question I had was regarding what laxatives are OTC and which are prescription in Ireland. I don't know if these differ from my (and other) country.
Response 4: We are grateful for this prompt to improve the international readability of the manuscript and have included explanatory content in the Discussion (lines 302-309).

R2/ C5: Table 1: Do you want to call them participants, patients, or patient participants? Consider different layout for this table, with columns for yes (n/percent), no (n /%), and missing. Would be easier to read.
Response 5: We agree with the importance of consistent terminology and have amended the manuscript to consistently use the term ‘patient participants’. While we appreciate the reviewer’s feedback with regards to the layout of Table 1, we are unfortunately unable to organise all data presented in this table into ‘yes/ no’ categories and so were unable to adopt this suggestion.

R2/C6: On page 5, report of CAS scores will make sense if information about the instrument is included in the earlier section.
Response 6: Thank you. The information has been included as suggested (lines 147-155) in the Data Collection section.

R2/ C7: Page 7: include the actual correlation coefficient before the p value.
Response 7: Thank you for noting this. We have amended the manuscript to include the correlation coefficient in the paragraph on Factors Associated with Constipation Burden (line 273).

R2/ C8: I had a question about laxative use that you may or may not be able to address in the discussion section: do patients typically self-medicate with laxatives, or do health professionals recommend they start with OTC laxatives?
Response 8: We have now incorporated additional information regarding self-medication practice in Ireland and an accompanying reference to lines 301-308 of the Discussion.

R2/ C9: The last sentence in the first paragraph of the Discussion is confusing. Consider more direct: The factors most commonly associated with constipation in this sample of cancer patients receiving palliative care were opioid use and female sex (has this been previously found?): And how about stressing enhanced systematic constipation assessment.
Response 9: We have amended the wording of the first paragraph of the Discussion as suggested to avoid confusion in presentation with data and to include reference to the general literature (lines 290-299). The importance of systematic constipation assessment has been highlighted (lines 333-334).

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Competing Interests

No competing interests to disclose

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Reviewer Report

32 Views

06 Dec 2021 | for Version 1

Bridget Candy, Marie Curie Palliative Care Research Department, Division of Psychiatry, University College London, London, UK

32 Views Cite this report Responses(1)

Approved With Reservations

Abstract and introduction: It would be expected for the introduction to include what was said in the abstract background but to say it in more detail. For example, why are prevalence estimates so wide (50 to 90%). Also to set this in context what is the prevalence of constipation in the general population.
Method:
- They use fairly old data – you need to mention this in the discussion.
- Helpful for readers to know more on the Bristol Stool Chart, as in number of items and what the items are.
- I note there is limited/no data collection on opioid intake, cancer severity, and ethnicity/cultural difference. All these factors will effect constipation/how patient manages constipation.
Results:
- The authors need to give the reader some indication of how representative the 491 patients were of all such patients in Ireland. Also what about refusal rate?
- Participant characteristics – you have not detailed whether prevalence differs between in and out-patients.
- Table 1 – it is not that informative to give detail as stated on cancer centre recruitment. For instance, why is there a range of recruitment rates. Is it the case that the larger centres provided more participants?
Discussion: Is this the first national survey in Ireland or even elsewhere – if so say so. They refer to your findings echoing other studies, it would be helpful if they could say whether these studies were in Ireland or elsewhere.
Conclusion: Add Ireland to the first sentence.

Is the work clearly and accurately presented and does it cite the current literature?

Partly
Is the study design appropriate and is the work technically sound?

Yes
Are sufficient details of methods and analysis provided to allow replication by others?

Yes
If applicable, is the statistical analysis and its interpretation appropriate?

I cannot comment. A qualified statistician is required.
Are all the source data underlying the results available to ensure full reproducibility?

No source data required
Are the conclusions drawn adequately supported by the results?

Partly

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

I am a palliative care researcher who has undertaken research in the treatment of opioid induced constipation

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Author Response

04 Jan 2023

Karen Ryan, University College Dublin, Dublin, D04 V1W8, Ireland

We appreciate the time given by the reviewers to providing valuable feedback and suggestions for strengthening the publication, and have edited the original draft accordingly. For each reviewer comment requiring action, we use the notation [R1/C1, R1/C2, etc], where R indicates which reviewer and C numbers each comment. We mark our responses to each comment as ‘response’. Of note, page lines refer to revised manuscript file submitted for typesetting.

R1/ C1: To make the article suitable for publication I would recommend some tightening in the writing, there are some redundant words and lack of order/flow between sections. The authors interchange between palliative care and Palliative Care. The results presentation does not follow the order set out in methods, as in first prevalence and then severity and then management. If they follow this in the abstract, results and then in brief in the discussion it will make the paper clearer.
Reponse 1: Thank you. We have edited the manuscript according to suggestions by ensuring consistency of terminology, and by making changes to improve the flow and order of narrative (lines 219-221; 302-305; 313-317; 368). We have ordered the presentation of results as recommended (lines 228-250).

R1/ C2: It would be expected for the introduction to include what was said in the abstract background but to say it in more detail. For example, why are prevalence estimates so wide (50 to 90%). Also to set this in context what is the prevalence of constipation in the general population.
Reponse 2: We have incorporated suggested amendments in the Introduction by providing additional detail on the study context, prevalence of both constipation and cancer-related constipation in the population and also included greater detail on the impact of the condition on individual patients and society. The specific edits can be found at: lines 58-60; 62-67 (additional detail on prevalence and burden); 70-77 (additional detail on context).

R1/ C3: They use fairly old data – you need to mention this in the discussion.
Response 3: The year of data collection is stated in the Methods section (study design and subjects), but we agree that this would also form a useful part of the Discussion section in line with the reviewer’s commentary. Accordingly, we have added a line discussing this to the paragraph on study limitations in the DIscussion (lines 351,352)

R1/ C4: Helpful for readers to know more on the Bristol Stool Chart, as in number of items and what the items are.
Response 4: We have provided additional content on both the Bristol Stool Chart and the Constipation Assessment Scale in the second and third paragraphs of the Data Collection section (lines 147-155 and 159-166)

R1/ C5: I note there is limited/no data collection on opioid intake, cancer severity, and ethnicity/cultural difference. All these factors will effect constipation/how patient manages constipation

Response 5: Thank you; we agree that further exploration of these factors would be of interest. In our study the selection of data items for collection was based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. We acknowledge that trade-offs are an integral part of making decisions about what data to collect and that it is important to point to limitations associated with data collection choices. We have therefore added content responding to the reviewer’s observations to the paragraph on study limitations in the Discussion (lines 352-360).

R1/ C6: The authors need to give the reader some indication of how representative the 491 patients were of all such patients in Ireland. Also what about refusal rate? Participant characteristics – you have not detailed whether prevalence differs between in and out-patients. Table 1 – it is not that informative to give detail as stated on cancer centre recruitment. For instance, why is there a range of recruitment rates. Is it the case that the larger centres provided more participants?
Response 6: Thank you for noting this; we agree that a greater understanding of representativeness of the sample would be of value, we are unfortunately unable to provide this information as census data on attendance at cancer centres in Ireland is not routinely collected. Decisions regarding data collection were based on consideration of ensuring that data collection did not place excessive burden on study participants who were attending hospital for cancer treatment, gatekeeper concerns regarding requirement for explicit consent for data processing and on resources available to carry out the study. In particular, our study was conducted at a time of changing data protection laws in Ireland and gatekeeper concerns regarding the requirement for explicit consent for data processing resulted in restrictions on data collection being applied. As familiarity and experience with enactment of GDPR has grown in the intervening period, it would be expected that it would be possible to collect this data in future studies. We have added discussion of these limitations at lines 337-346 of the Discussion.

R1/ C7: Is this the first national survey in Ireland or even elsewhere – if so say so. They refer to your findings echoing other studies, it would be helpful if they could say whether these studies were in Ireland or elsewhere.
Response 7: This is the first national survey of constipation in patients attending cancer centres in Ireland, and to our knowledge, elsewhere. In response to the reviewer’s comments, we have included this detail and additional detail on other cited studies to help the reader better understand context of studies and comparability (lines 291-300) in the Discussion.

R1/ C8: Add Ireland to the first sentence.
Response 8: The manuscript has been amended to add this (line 366).

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Competing Interests

No competing interests to disclose

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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A national cross-sectional survey of constipation in patients attending cancer centres in Ireland

Abstract

Keywords

Introduction

Methods

Ethics statement

Study design and subjects

Data collection

Analysis

Results

Participants

Table 1. Participant characteristics.

Constipation Assessment Scale score

Table 2. Constipation Assessment Scale scores.

Bristol Stool Chart

Laxative use

Factors associated with constipation burden

Table 3. Ordered logistic regression examining factors associated with constipation burden.

Table 4. Random effects logistic regression examining factors associated with laxative use.

Factors associated with laxative use

Discussion

Conclusion

Data availability

Underlying data

Extended data

Acknowledgements

References

Comments on this article Comments (1)

Open Peer Review

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Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Are you a HRB-funded researcher?

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A national cross-sectional survey of constipation in patients attending cancer centres in Ireland

Abstract

Keywords

Introduction

Methods

Ethics statement

Study design and subjects

Data collection

Analysis

Results

Participants

Table 1. Participant characteristics.

Constipation Assessment Scale score

Table 2. Constipation Assessment Scale scores.

Bristol Stool Chart

Laxative use

Factors associated with constipation burden

Table 3. Ordered logistic regression examining factors associated with constipation burden.

Table 4. Random effects logistic regression examining factors associated with laxative use.

Factors associated with laxative use

Discussion

Conclusion

Data availability

Underlying data

Extended data

Acknowledgements

References

Comments on this article Comments (1)

Open Peer Review

Comments on this article Comments (1)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Competing Interests Policy

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Are you a HRB-funded researcher?

Thank you!